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FDA ANDA · ANDA202964

DICLOFENAC POTASSIUM

Sponsor: PH HEALTH

APPLICATION
ANDA202964
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-02
LATEST ACTION
2023-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

DICLOFENAC POTASSIUMPrescription
DICLOFENAC POTASSIUM 50MG · FOR SOLUTION · ORAL

Approval history

2023-05-01Labeling · Supplement 3 · standardAP
2020-11-09Labeling · Supplement 2 · standardAP
2020-11-09Labeling · Supplement 1 · standardAP
2016-05-02UNKNOWN · OriginalLabelAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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